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nchsls:c:general:document:03

Document control Procedure

NameUnique ID Edition/Date of Edition
Procedure for control of recordsnchsls:c:general:document:03(1) 03-01-2014
Preparing authorityApproving authorityReview period
All teaching staffQuality Manager1 year
Printed copy of this document is considered uncontrolled. It should be compared with controlled electronic copy before use

Processes requiring this procedure

All processes need this procedure for maintaining records in ways that serve their intended purposes.

Purpose

Procedure for control of records ensures that identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records occure in ways that facilitate its intended use and prevent unintended use.

Scope

All records referenced directly or indirectly in quality manual are under the scope.

Users of the procedure

Any personnel of the laboratory involved with identification, collection, indexing, access, storage, maintenance, amendment and safe disposal of quality and technical records need to use this procedure.

Procedure

  1. Collect details of a record as early as possible after completion of activity. This reduces error due to memory lapses. Such details may be text, photographs, scatches, video and audio or any other format.
  2. Record name of activity . e.g record of temprature
  3. Record primary key of activity. e.g date and time of record, serial number of record. Such key help differenciate records of the same name from each other.
  4. Record date/time of record creation and person responsible for creation( not necessarily as part of record itself).
  5. name of activity and primary key together is identification of a record.
  6. Store the record physically or electronically as long as medically relevant or as required by regulation. Take following care for stored records.
    1. Include guidelines regarding storage period and other instructions in the procedure referencing the record.
    2. Make sure it is accessible to those who are authorized to access it.
    3. Make sure it is not accessible to those who are not authorized to access it.
    4. Make sure that storage condition donot cause damage, deterioration or loss of records.
    5. Take regular backup of electronic records.
  7. use record identification for indexing and access (retrival) of record at a future date. Other properties of record can also be used for simmilar purpose. e.g name of refrigerator.
  8. Whenever a record is amended, record date/time of amendment and preserve older data if relevent.
  9. Whenever a stored record is not required clinically or by any rules and regulations or otherwise, dispose it taking care that its disposal donot result in unauthorized access of records.
  10. Whenever asked ,provide record and its analysis to the laboratory management.
nchsls/c/general/document/03.txt · Last modified: 2022/08/13 07:34 (external edit)